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Steamer Line: Installation and Operating Instructions Hollow Fiber Cartridges
Steamer Line: Installation and Operating Instructions Hollow Fiber Cartridges
M: 25 M: 0
Y: 15 Y: 0
K: 0 K: 0
Installation and
Operating
Instructions
Steamer Line
Hollow Fiber
Cartridges
www.watersep.net
Designed for perfusion and aseptic applications, WaterSep’s Steamer Line autoclavable
hollow fiber cartridges are gamma irradiated and ready to use. They do not contain
humectant and are pre-wetted with deionized water so minimal flushing is needed
before use. The cartridges can be cleaned, stored and autoclaved up to five (5) times.
Contents:
1. Connect the Steamer cartridge into a crossflow system.
2. Autoclave the Steamer cartridge or system, if required for your application.
3. Measure the water flux and normalized water permeability if intended to reuse.
4. Integrity test the Steamer cartridge.
5. Condition the Steamer cartridge with buffer before introducing product.
6. Run the filtration process and recover your product.
7. Clean the Steamer cartridge if intended to reuse.
8. Store the Steamer cartridge.
9. Flush the Steamer cartridge to remove the storage solution.
Installation & Operating
PR
RETENTATE
PP
PERMEATE
WaterSep
RESERVOIR
CARTRIDGE
PF
FEED
Maximum
Maximum Maximum Operating
Transmembrane
Feed Pressure Temperature pH Range
Pressure (TMP)
bar psi bar psi °C °F
To re-wet the cartridge and system, fill the reservoir with water. Start the feed pump at a slow speed. Use a pinch
valve on the retentate to generate backpressure and transmembrane pressure (TMP) to get permeate flow through
the fibers. Slowly increase the pump speed so the TMP = 0.5 — 10 psig to wet the cartridge and remove air from the
system. TMP is calculated using the equation:
Direct the retentate and permeate to waste. During flushing, adjust the retentate backpressure. After the cartridge and
system is re-wetted, decrease the feed pump speed then stop the feed pump and discard the waste.
(Water) Flux
Open the permeate valve and adjust the retentate valve so the TMP is = 0.5 — 5 psig of water. Measure and record
the following data: 1) permeate flow rate in mL/min; 2) feed pressure in psi; 3) retentate pressure in psi; 4) permeate
pressure in psi; and 5) permeate temperature in degrees Celsius. Flux, with units of Liters per square meter per hour
(LMH), is calculated using the equation:
Flow
Rate min ( mL
)
x 0.06
Surface Area (m2)
Flux (LMH)
Water Permeability at 20°C =
TMP (psig)
If the actual water temperature for the permeability test is not 20°C, the water permeability calculated above
should be normalized to 20°C with a temperature correction factor (TCF) from Table 2. The Normalized Water
Permeability is calculated using the equation:
PR
RETENTATE
PP
PERMEATE
WaterSep
CARTRIDGE
FEED PF
Table 2: Temperature Correction Factors for Water Temperatures from 5°C — 50°C
TCF 1.520 1.308 1.139 1.002 0.891 0.798 0.720 0.653 0.596 0.547
CAUTION: Use only white plastic (nylon) clamps on cartridges with sanitary fittings.
Instructions Steamer Line Hollow Fiber Cartridges
6. Run the perfusion or crossflow filtration process and recover your product
PERFUSION PROCESS
Connect the perfusion system to the bioreactor and begin perfusing based on the conditions for your application.
Perfusion rates can range from 0.2 vessel volumes per day (VVD)—2 VVD or more, depending on your prcedure.
After processing the cartrdige can be cleaned for reuse or discarded.
CROSSFLOW PROCESS
Set your flow rate
Connect or add the process feed to the reservoir. Route the retentate and permeate tubing to the appropriate
containers for your process. Close the permeate valve and start the feed pump at a slow speed to recirculate the
process fluid. Slowly increase the pump speed and open the permeate valve to achieve the crossflow feed and
permeate flow rate for your cartridge per the Flow Rates on Table 4. If needed, use the retentate valve to change the
retentate backpressure to achieve the permeate flow rate for your cartridge.
A typical TMP range for a concentration/diafiltration process is 10—30psi (0.7—2Bar) and for a cell harvest/
clarification process is 3 —10psi (0.2—0.7Bar). Pressures observed during filtration should not exceed the maximum
Operating Limits (Table 1).
For optimal product recovery at the end of processing, close the permeate valve and release the retentate
backpressure. Recirculate the fluid for 5—10 minutes to allow product to re-enter the bulk solution flow.
Pressures observed during filtration should not exceed the maximum Operating Limiits (Table 1). Once you have
recovered your retentate or permeate product, then stop the pump(s). Disconnect the product.
clean the feed/retentate with fresh cleaning reagent, discard the reagent used for cleaning the feed/retentate, then
use fresh cleaning reagent to clean the permeate.
Table 3: Suggested chemical cleaning reagents (Note: Do not exceed a maximum temperature of 40°C)
Table 4: Cartridge Model Length, Membrane Surface Area and Sample/Batch Volume
LMH Permeate
30 Ultrafiltration 0.16 0.32 0.58 0.47 1.0 1.7
Materials of Construction
The product as assembled is USP Class VI compliant.
Membrane: Modified Polyethersulfone (m-PES) Housing: Polysulfone Encapsulant: Medical Grade Epoxy
12¨ 24¨ 41¨ 12¨ 24¨ 41¨ 12¨ 24¨ 41¨ 12¨ 24¨ 41¨
0.044 0.094 0.172 0.13 0.28 0.51 0.61 1.35 2.50 1.21 2.69 5.00
WaterSep provides
Hollow Fiber
Crossflow Filtration
from Concept to
Completion. Our
Products are Easy
to Use and Tailored
to Your Specific
Filtration Application.
www.watersep.net
ReUse Line
Designed for those applications where cleaning and reuse is acceptable, ReUse Line cartridges can be cleaned,
rinsed, stored and used up to twenty (20x) in the same application.